An Internal Monitor vacancy is available at our Client, Wits Health Consortium’s Clinical HIV Research Unit (CHRU) in Port Elizabeth – Eastern Cape.
Wits Health Consortium (Pty) Limited (“WHC“) is a wholly-owned Company of the University of the Witwatersrand, Johannesburg (South Africa) under its Faculty of Health Sciences. WHC provides Faculty with a legal framework within which to operate the research and other activities necessary to support its academic objectives. In addition, WHC offers a range of products and services to the Academics conducting these activities in order to assist with the management thereof.
The Clinical HIV Research Unit (CHRU) was initiated in 1998 by Professor Ian Sanne, under the auspices of the University of the Witwatersrand (WITS). Today the CHRU is an HIV/AIDS, TB and Cervical Cancer research syndicate of the Wits Health Consortium (Pty) Limited (WHC), which is a wholly-owned subsidiary company of WITS.
The CHRU is proudly the first International Clinical Research Site (CRS) of the AIDS Clinical Trials Group (ACTG). To date, it remains one of the most successful international sites within the ACTG. The site is substantially funded by the National Institutes of Health (NIH) and USAID/PEPFAR.
Based at the Helen Joseph Academic Hospital in Johannesburg, the CHRU conducts research into HIV-AIDs, carrying out clinical trials that encompass associated dread diseases (TB, Cervical Cancer and other opportunistic infections) and provides technical expertise and assistance, training of health care personnel, quality assurance assessments of sites, and clinical support services
Main purpose of the job
- To assist with the performance of clinical trial-related duties in line with Good Clinical Practice (GCP) standards and be responsible for (1) internal monitoring and validation of patient files to ensure completeness and data consistency and (2) compiling of site regulatory and essential documents to all required stakeholders: Ethics Committees, South African Health Products Regulatory Authority and other regulatory bodies
- José Pearson TB Hospital, Port Elizabeth
Key performance areas
- Ensure a thorough understanding of the project protocol and the SSP manuals
- Participate in Project Team meetings as required and provide constructive feedback and support to other team members
- Maintain a positive and constructive partnership with study Investigators and other site staff through constructive feedback, provision of assistance and active problem solving
- Conduct Quality Control activities for the clinical trials, assist with regulatory communications and adherence and train the site personnel in the protocol and its requirements
- Review and Assess Case Report Forms, Informed Consents and Standard Operating Procedures
- Ensure all queries are attended to appropriately and in a timely manner
- Discuss QC trends with the study team during team meetings
- Pay particular attention to trends in the QC findings and to conduct refresher training where necessary
- Ensure the defined protocol is adhered to at all times
- Ensure all required protocol parameters are followed and recorded accurately at all times
- Ensure study staff is following study standard operating procedures at all times
- Assist with preparation and follow-up of external monitoring visits and audits
- Training/corrective action for site staff based on QC/QA/External monitoring findings in conjunction with Managers
- Report and track critical events and protocol deviations as notifications occur
- Develop and/or review study-specific SOPs when required
- Prepare site regulatory and essential documents in a timeous and accurate manner to all applicable ethics, regulatory bodies and sponsors
- Track submissions and approval status
- Maintain regulatory documents
- Conduct internal monitoring of regulatory files
- Generate regulatory reports as required
- Communication with internal and external stakeholders
Required minimum education and training
- Degree in Health Care or other Scientific Discipline
- GCP qualification
- A recognized Quality Control Course (for clinical trials)
- Computer literacy at a higher level including the use of MS Word, Excel and Email and Internet
Desirable additional education, work experience and personal abilities
- Require good organizational, administrative and analytical skills
- Time Management
- Extremely well organized and resourceful
- Analytical Ability
- Ability to work independently
- Ability to work in a high-pressure environment
- Attention to detail
- Attention to detail
- Ability to apply consistent adherence to intentional research and GCP practices
- Ability to communicate effectively within the study team and with external stakeholders
- Very time conscious
- Flexible and able to multitask
Required minimum work experience
- At least 3 years’ experience in quality control procedures in clinical trials
- At least 5 years’ experience working in clinical trials
- At least 2 years’ regulatory experience
- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV – Please Apply Online
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- The closing date for all applications is 02 November 2020.
- Wits Health Consortium will only respond to shortlisted candidates.
- Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful.
- In accordance with our Employment Equity goals and plan, preference will be given to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.
Please note that AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
AJ Personnel does not have any salary or other information regarding the position.